视网膜下注射康柏西普治疗难治性新生血管性老年性黄斑变性的疗效和安全性

Efficacy and safety of subretinal injection of conbercept in the treatment of refractory neovascular age-related macular degeneration

目的探讨视网膜下注射康柏西普治疗难治性新生血管性老年性黄斑变性(nAMD)的疗效和安全性。方法本研究为前瞻性临床研究。选取2022年3月至2023年9月就诊于南昌大学附属眼科医院眼底病科诊断为难治性nAMD的患者17例(17眼)作为研究对象。利用41G超精微针将10 g·L^(-1)康柏西普注射液注入患者黄斑区视网膜下。术后随访期间若OCT发现黄斑区视网膜有渗出,则继续行玻璃体内注射10 g·L^(-1)康柏西普。记录患者术前,术后1个月、3个月、6个月、12个月最佳矫正视力(BCVA)和黄斑区视网膜厚度(CMT)以及注药次数、并发症发生情况。结果与术前相比,术后1个月、3个月、6个月和12个月患者BCVA均得到显著改善(均为P<0.001)。术后各时间点患者BCVA变化不明显(均为P>0.05)。与术前相比,术后1个月、3个月、6个月和12个月患者CMT均显著降低(均为P<0.001)。术后1~12个月患者CMT有随着时间的推移逐渐下降的趋势(均为P<0.001)。Pearson相关性分析结果显示,术前BCVA与术前CMT之间、术前BCVA与术后12个月BCVA之间均存在正相关关系(r=0.643,P=0.005;r=0.634,P=0.006)。治疗期间,17眼抗VEGF注药次数为(1.35±0.61)次,其中12眼1次,4眼2次,1眼3次。经相关分析发现,注药次数与患者术前CMT呈正相关(r=0.664,P=0.004)。17眼患者术中和术后均未发生与手术相关的并发症。结论视网膜下注射康柏西普治疗难治性nAMD是一项安全有效的治疗方法,可降低CMT并改善患者视力预后。

Objective To explore the efficacy and safety of subretinal injection of conbercept in treating refractory neovascular age-related macular degeneration(nAMD).Methods In this prospective clinical study,17 eyes of 17 patients diagnosed with refractory nAMD at the Department of Fundus Disease,the Affiliated Eye Hospital of Nanchang University from March 2022 to September 2023 were enrolled.The 10 g·L^(-1)conbercept was injected into the subretinal area of the macular area using a 41G ultra-fine microneedle.If retinal exudation was found in the macular area by optical coherence tomography during the follow-up,the intravitreal injection of 10 g·L^(-1)conbercept was performed.The best corrected visual acuity(BCVA),central macular retinal thickness(CMT),number of injections and complications were recorded before and 1,3,6,and 12 months after the operation.Results Compared with the preoperative values,the BCVA of patients significantly improved(all P<0.001)1,3,6 and 12 months postoperatively.There was no significant change in BCVA at each time point after operation(all P>0.05).Compared with pre-operation,CMT of patients significantly decreased at 1,3,6 and 12 months after operation(all P<0.001).From 1 month to 12 months after the operation,the CMT of patients gradually decreased(all P<0.001).Pearson correlation analysis showed that there were positive correlations between preoperative BCVA and preoperative CMT,preoperative BCVA and 12-month postoperative BCVA(r=0.643,P=0.005;r=0.634,P=0.006).During the treatment,the number of anti-vascular endothelial growth factor injections in 17 eyes was(1.35±0.61)times,with 1 time in 12 eyes,2 times in 4 eyes,and 3 times in 1 eye.Correlation analysis showed that the number of injections was positively correlated with preoperative CMT(r=0.664,P=0.004).No intraoperative or postoperative complications related to the operation occurred in 17 eyes.Conclusion Subretinal injection of conbercept,which can reduce CMT and improve visual prognosis,is a safe and effective treatment method for refractory nAMD.